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"We believe sugammadex is an important innovation, and will work closely with the FDA to bring this product to hospitals, surgeons, anesthesia professionals and patients in the United States"

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the company has received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) for the resubmission of
the New Drug Application for sugammadex sodium injection, Merck’s
investigational medicine for the reversal of neuromuscular blockade
induced by rocuronium or vecuronium.

The FDA’s letter raised concerns about operational aspects of a
hypersensitivity study that the agency had requested in 2008. Merck is
evaluating the Complete Response Letter and expects to be able to
determine a path forward in the very near future.

“We believe sugammadex is an important innovation, and will work closely
with the FDA to bring this product to hospitals, surgeons, anesthesia
professionals and patients in the United States,” said David Michelson,
M.D., head of global neuroscience clinical development, Merck Research
Laboratories.

As previously disclosed, the FDA cancelled the discussion of sugammadex
at the July 18th Anesthetic and Analgesic Drug Products Advisory
Committee (AADPAC). At that time, the FDA advised Merck that the agency
needed additional time to assess the results of the agency’s recently
completed inspection of a clinical trial site conducting the
hypersensitivity study.

Neuromuscular blockade is used in anesthesiology to induce muscle
relaxation during surgery. Sugammadex is designed to work by
inactivating rocuronium or vecuronium, two neuromuscular blocking
agents, directly by encapsulation. If approved, sugammadex would be the
first in a new class of medicines, known as selective relaxant binding
agents, to be used in the U.S. Sugammadex is currently marketed in more
than 50 countries other than the U.S., and more than 5 million vials
have been sold as of June 2013.

About Merck

Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
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Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2012 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (www.sec.gov).